Regulatory Compliance Solutions

  1. Combination Products 4/28/2022

    Kymanox provides turnkey services to bring your product from concept to commercialization — and helps keep your product on the market. Kymanox has expertise in injectables (e.g., syringes, mechanical and electromechanical autoinjectors, wearable injectors, dual chamber systems, reconstitution systems), respiratory combination products (e.g., metered dose inhalers, dry powder inhalers, nasal sprays), and in ocular products (e.g., multi-dose containers, single-use injectables).

  2. Compliance & Regulatory Programs For Drug Manufacturing 10/25/2024

    Our experts implement proven, streamlined processes that maintain compliance, quality standards, and efficiency while also managing costs, schedules, and scope.

     

  3. Axon Digidata 1550B Low-Noise Data Acquisition System Plus HumSilencer 6/20/2023

    High-resolution, low-noise digitizer with 50/60 Hz line-frequency noise elimination.

  4. Fast, Compact Absorbance Microplate Reader For a Wide Range Of Assays 6/20/2023

    Filterless readers provide consistent results with steady temperature regulation

    The SpectraMax® ABS and ABS Plus absorbance microplate readers provide the flexibility, sensitivity, and convenience for a wide range of assays such as ELISAs, microbial growth, and protein quantitation. Both readers feature an 8-channel read head for fast reads and a subset feature, the temperature independent PathCheck sensor that automatically normalizes and ensures accurate absorbance values by detecting pipetting errors. Combined with a wide application base, industry-leading SoftMax® Pro Software and validation tools, these readers fit in every lab and every budget.

  5. Batch Execution Module 3/7/2025

    Ecolab’s Batch Execution Module enhances pharmaceutical manufacturing with AI-driven scheduling, real-time monitoring, automated compliance checks, and proactive alerts to improve efficiency, quality, and regulatory adherence.

  6. High-Quality Imaging For Up To Four-Color Microarrays On The GenePix Microarray Systems 6/21/2023

    Microarray scanners for one-fluor to multi-fluor applications

    The GenePix® Microarray Systems are based on 25 years of expertise in low-noise signal amplification and optical design. The systems can handle any slide-based microarray study, from small one- or two-fluor applications to multiple-fluor high-throughput projects requiring automated sample handling and secure enterprise-wide data management and analysis. All GenePix scanners include one license of GenePix Pro Image Acquisition and Analysis Software, the benchmark tool for the acquisition and analysis of microarray images.

  7. Cleanrooms And Equipment For Cell Therapy Drug Manufacturing 6/9/2023

    Delivering on the promise of cell and gene therapy through Germfree products and services.

    Germfree Laboratories offer advanced modular and mobile facilities, equipment, and comprehensive services for cell therapy manufacturing. Acknowledging the complexity of personalized treatments, Germfree’s adaptable solutions optimize production processes, ensuring aseptic conditions, scalability, and compliance with regulatory standards. This enables efficient, high-quality cell therapy delivery to patients in need, supporting manufacturers in overcoming industry challenges.

  8. Scientific Insights Lab Simplifying The Journey From Molecule To Market

    Drug development programs should aid customers in the successful mitigation of technical and regulatory risks to ensure drug products move swiftly through the regulatory approval process and into commercialization. Get service and support to help pharmaceutical and biopharmaceutical manufacturers Simplify the Journey™ from molecule to market.

  9. Remote Cleanroom Microbial Air Sampler (Annex 1-Compliant) 12/1/2022

    The MiniCapt® Pro Remote Microbial Air Sampler from Particle Measuring Systems (PMS) incorporates the latest viable cleanroom monitoring technologies into one instrument to customize cleanroom and aseptic area microbial monitoring according to ISO Class 5/7, GMP Grade A/B, and for use in background areas monitored by a Facility Monitoring System (FMS).

  10. Annex 1-Compliant Real-Time Viable Particle Counter 12/15/2022

    What Is Annex 1 and Why Is It Important? Annex 1 is a GMP document published by the European Commission and dedicated to the manufacturing of sterile products. All pharmaceutical companies that produce sterile products must comply with these regulations. The document is a joint initiative between the EMA and PIC/S.